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Genetic and Environmental Factors in Adults With Low and High Caries Experience

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ClinicalTrials.gov Identifier: NCT04124718
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital

Brief Summary:
VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and susceptibility in adults.

Condition or disease Intervention/treatment
Low Caries Experience High Caries Experience Genetic: high caries experience

Detailed Description:

To date, genes can be grouped into categories based on the factor influencing dental caries. The major candidate gene categories to date include enamel formation genes, immune response genes, genes related to saliva, and genes related to taste and dietary habits.

TFIP11 and VDR genes are related to enamel formation genes


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Week
Official Title: VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : December 20, 2019

Group/Cohort Intervention/treatment
high caries experience
80 adults will be allowed in the high caries experience group according to DMFT index DMFT>13.9
Genetic: high caries experience
DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
Other Name: DNA isolation, genotyping

low caries experience
80 adults will be allowed in the high caries experience group according toDMFT index DMFT≤4
Genetic: high caries experience
DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
Other Name: DNA isolation, genotyping




Primary Outcome Measures :
  1. past caries experience [ Time Frame: 3 months ]
    Each tooth will be examined and recorded as decayed, missing, or filled


Secondary Outcome Measures :
  1. Plaque index [ Time Frame: 3 months ]
    The plaque amount is scored by using Silness&Löe Plaque Index plaque index PI<1.0 healthy PI 1.1-2.0 mild PI>2 high plaque


Biospecimen Retention:   Samples With DNA
DNA for genetic analysis was isolated from buccal epithelial cells


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Ages Eligible for Study:   24 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study
Criteria

Inclusion Criteria:

  • adult be between 24 and 40 years old
  • subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) DMFT≤4 , or, DMFT>13.9

Exclusion Criteria:

  • systemic or genetic disorders
  • orthodontic appliances
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124718


Contacts
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Contact: Gül Yıldız Telatar, dr 05365404555 gulyildiz@gmail.com
Contact: Faruk Saydam, dr 05052419232 faruk.saydam@erdogan.edu.tr

Locations
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Turkey
Recep Tayyip Erdogan University Dentistry Faculty Recruiting
Rize, Turkey, 53000
Contact: Gül Yıldız Telatar, Dr    05365404555    gulyildiz@gmail.com   
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Principal Investigator: Gül Yıldız Telatar, dr Recep Tayyip Erdogan University Dentistry Faculty

Additional Information:
Publications:
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Responsible Party: Gul Yildiz Telatar, Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04124718     History of Changes
Other Study ID Numbers: 2016-30
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available within 6 months of study completion
Keywords provided by Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital:
caries experience, VDR, TFIP11, enviromental risk factor